ILUVIEN® Implant for Diabetic Macular Edema

(NEW DAY Trial)

Not currently recruiting at 38 trial locations

Overseen By Ashley Gantt

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Alimera Sciences

Must not be taking: Steroids, Aflibercept, Ranibizumab, others

Disqualifiers: Proliferative diabetic retinopathy, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for diabetic macular edema, a condition where fluid accumulates in the eye, affecting vision. The study compares two treatments: an ILUVIEN implant, which slowly releases medication directly into the eye, and a series of aflibercept injections, a medication that helps reduce eye swelling. The goal is to determine which approach works better for individuals who haven't recently received treatments for their eye condition. Ideal participants have diabetic macular edema, haven't received certain eye treatments in the past year, and don't have other eye conditions like glaucoma or proliferative diabetic retinopathy. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, helping researchers understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it does mention that participants should not have received certain eye treatments in the last 12 months. It's best to discuss your current medications with the trial team.

What is the safety track record for these treatments?

Research has shown that the ILUVIEN implant, used to treat diabetic macular edema, has undergone safety testing in people. Over three to five years, many patients maintained or improved their vision. The implant was generally well-tolerated, with most people not experiencing serious side effects. Some minor side effects were reported, but the benefits of improved vision outweighed these.

For those considering this treatment, evidence suggests it is generally safe and effective. Patients have used it for several years with positive results. Therefore, those considering joining a trial can be assured that this implant has a good safety record over time. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard diabetic macular edema treatments that often involve repetitive anti-VEGF injections, ILUVIEN® offers a different approach with its long-lasting steroid implant. This implant releases fluocinolone acetonide, a corticosteroid, slowly over an extended period, reducing the need for frequent injections. Researchers are excited because ILUVIEN® has the potential to maintain vision improvements with fewer interventions, which could lead to better patient adherence and overall quality of life. Additionally, ILUVIEN® directly targets inflammation, a key factor in diabetic macular edema, potentially providing a more comprehensive treatment option.

What evidence suggests that this trial's treatments could be effective for diabetic macular edema?

Studies have shown that the ILUVIEN implant, which participants in this trial may receive, can help people with diabetic macular edema (DME) by improving vision and reducing the need for other treatments. Many patients have maintained stable or improved vision for several years. Aflibercept, another treatment option in this trial, effectively treats DME by improving vision and reducing retinal swelling. Clinical studies and real-world use have proven both treatments to be safe and effective. ^{6 7 8 9 10}

Who Is on the Research Team?

Samer Kaba, MD

Principal Investigator

Alimera Sciences, Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 with early Diabetic Macular Edema (DME) confirmed by SD-OCT and specific vision acuity scores. It's not for those with advanced diabetic eye disease, other causes of macular edema, recent certain eye treatments, or uncontrolled glaucoma.

Inclusion Criteria

My vision in the study eye is somewhat impaired but not severely.

Must have CI-DME confirmed by Spectral Domain Ocular Coherence Tomography (SD-OCT) and Center Subfield Thickness (CST) of: ≥350 µm in the study eye

Exclusion Criteria

I have or had high eye pressure, glaucoma, or a significant eye condition.

Steroid Challenge Exclusion Criterion- At the Baseline Visit, patients who are determined to have an IOP ≥25 mmHg or an increase ≥8 mmHg from Screening will be excluded from the study.

I have not had certain eye treatments in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either ILUVIEN intravitreal implant followed by supplemental aflibercept as needed, or intravitreal aflibercept loading dose followed by supplemental aflibercept as needed

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aflibercept
• Iluvien 0.19 MG Drug Implant

Trial Overview The study compares two DME treatments: an ILUVIEN implant followed by as-needed aflibercept injections versus a series of aflibercept injections alone. The goal is to see if ILUVIEN can be an effective initial treatment.

How Is the Trial Designed?

Group I: Aflibercept Arm Active Control 1 Intervention

Intravitreal aflibercept

Group II: ILUVIEN Arm Active Control 2 Interventions

Intravitreal ILUVIEN

Who Is Running the Clinical Trial?

Alimera Sciences

Lead Sponsor

Trials

14

Recruited

3,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12496451/

Real-World Functional and Anatomic Outcomes With ... Purpose: To assess clinical outcomes in diabetic macular edema (DME) patients treated with high-dose aflibercept 8.0 mg (HDA), focusing on ...

2. eyleahcp.us eyleahcp.us/s/eylea/diabetic-macular-edema-vision-outcomes

DME: Vision Outcomes - eylea EYLEA Achieved Rapid and Sustained Outcomes in DME · EYLEA® (aflibercept) Injection mean change in BCVA year 1, Chart ; EYLEA Improved Vision from 20/63 to 20/40.

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT02772497

NCT02772497 | 3 Month Outcome of Ziv-aflibercept for DME Multi-studies have shown that Intravitreal aflibercept (Eylea) is effective and safe in diabetic macular edema (DME) treatment and has gained FDA approval but ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2950253525000358

Short-term outcomes of faricimab and aflibercept 8 mg in ... Faricimab and aflibercept 8 mg show comparable efficacy in treating DME. Both treatments significantly improve BCVA and reduce central retinal thickness.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9486998/

Efficacy and Safety of Aflibercept Therapy for Diabetic Macular ... Aflibercept is effective at improving visual and anatomical outcomes in patients with DME, both in highly controlled settings and in a real-life environment.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36513858/

Clinical efficacy and safety of intravitreal fluocinolone ... Our real-world results confirm the efficacy of the ILUVIEN implant over 5 years, with two-thirds of eyes having improved or stable visual acuity 5 years after ...

7. aaojournal.org aaojournal.org/article/S0161-6420(22)00067-7/fulltext

Three-Year Safety and Efficacy of the 0.19-mg ... In patients with DME, the 0.19-mg FAc implant provided improved visual outcomes and reduced treatment burden compared with previous treatments while maintaining ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04469595

NCT04469595 | A Study of Intravitreal ILUVIEN® Implant ... The study will compare 2 treatment regimens: ILUVIEN intravitreal implant (0.19 mg) followed by supplemental aflibercept as needed per protocol criteria (2 mg/ ...

9. nature.com nature.com/articles/s41433-022-02338-2

Clinical efficacy and safety of intravitreal fluocinolone ... Our real-world results confirm the efficacy of the ILUVIEN implant over 5 years, with two-thirds of eyes having improved or stable visual acuity 5 years after ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0002939422003749

The 0.19-mg Fluocinolone Acetonide Intravitreal Implant ... PALADIN was a prospective study to assess real-world safety-related and functional outcomes 3 years after FAc implant in patients with DME for whom previous ...